A study of lurbinectedin in combination with atezolizumab compared with atezolizumab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) following first-line induction therapy with carboplatin, etoposide and atezolizumab

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Health Care [N] - Environment and Public Health [N06]

Trial duration

14 Feb 2022 → ongoing

Decision date (initial)

2024-07-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche Ltd

External identifiers

EU CT number

2023-503868-16-00

EudraCT number

2021-001930-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Others

To evaluate the efficacy of maintenance treatment with lurbinectedin in combination with atezolizumab compared with atezolizumab based on Independent Review Facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS)

Secondary objectives 4

1. To evaluate the efficacy of maintenance treatment with lurbinectedin in combination with atezolizumab compared with atezolizumab based on investigator-assessed PFS, confirmed objective response rate (ORR), duration of response (DOR), PFS rates at 6 months and 12 months, and overall survival (OS) rates at 12 months and 24 months
2. To evaluate the safety of maintenance treatment with lurbinectedin in combination with atezolizumab compared with atezolizumab based on incidence and severity of adverse events
3. To evaluate the immunogenicity of atezolizumab with and without lurbinectedin based on the prevalence of anti-drug antibodies (ADA) to atezolizumab throughout treatment
4. To evaluate the health-related quality of life of participants treated with lurbinectedin in combination with atezolizumab compared with atezolizumab

Conditions and MedDRA coding

Small-Cell Lung Cancer (SCLC)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically or cytologically confirmed ES-SCLC (per the VALG staging system)
2. Adequate hematologic and end-organ function
3. ECOG PS 0 or 1
4. No prior systemic treatment for ES-SCLC
5. Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy
6. Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better

Exclusion criteria 6

1. Presence or history of CNS metastases
2. Planned consolidative chest radiation
3. Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
4. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
5. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
6. Disease progression following induction treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. IRF-assessed progression-free survival (PFS) after randomization, defined as the time from randomization to the date of first occurrence of documented disease progression (as assessed by the IRF according to RECIST v1.1), or death from any cause (whichever occurs first)
2. 2. Overall Survival after randomization, defined as the time from randomization to the date of death from any cause

Secondary endpoints 8

1. 1. Investigator-assessed progression-free survival (PFS)
2. 2. Confirmed objective response rate (ORR) as determined by the IRF and investigator according to RECIST v1.1
3. 3. Duration of response (DOR) as determined by the IRF and investigator according to RECIST v1.1
4. 4. PFS rates at 6 months and 12 months as determined by the IRF and investigator according to RECIST v1.1
5. 5. OS rates at 12 months and 24 months
6. 6. Incidence and severity of adverse events, including serious adverse events and adverse events of special interest in randomized participants, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
7. 7. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at induction phase baseline and incidence of ADAs to atezolizumab after drug administration by treatment group
8. 8. Time to confirmed deterioration (TTCD) from randomization in patient reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 12

Locations

7 EU/EEA countries · 43 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 80 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications